MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE

Catalog Number AE05ML

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that while loading the clips on the applier, the clips could not be loaded properly and are not remaining on the applier.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73g1800292 was manufactured on 07/16/2018 a total of 288 pieces.Lot was released on 07/26/2018.Dhr investigation did not show issues related to complaint.The customer returned one unit ae05ml autoend05 ml for investigation.The sample was reviewed with a r & d engineer.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with its top jaw appearing to be slightly higher than its normal position.First, the jaw was pushed back in place upon application of light pressure.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, an audible ratchet sound was heard indicating that the internal ratchet ears are intact.The first clip was able to properly load into the jaws of the device.However, the clip was unable to be applied to over-stressed surgical tubing.It was observed that the jaws misaligned upon application.This was repeated with the same result for the second clip.The device was disassembled in order to inspect the internal components.Upon disassembly, it was found that the jaws were bent.No other damages were observed.The device was returned with 8 clips remaining indicating that 7 clips were fired by the end user.The damage to the jaws caused the jaws to misalign and prevented the clips from being able to be successfully applied to over-stressed surgical tubing.It could not be determined what caused the jaws to bend.The ifu for this product, l06072, was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip." a corrective action is not required at this time as the condition of the sample received indicates that unintentional user error caused or contributed to this event.The reported complaint of "when clip was being closed, it broke" was confirmed based upon the sample received.Upon functional inspection, it was found that the jaws were bent which caused the jaws to misalign and prevented the clips from being successfully applied to over-stressed surgical tubing.At the time of manufacturing assembly, the autoendo5 is 100% inspected for proper clip loading and closure.It is unlikely that this type of damage was present at the time of manufacturing.A device history record review was performed on the device with no evidence to suggest a manufacturing related defect.Based upon the observed damage, unintentional user error caused or contributed to this event.

Event Description

It was reported that while loading the clips on the applier, the clips could not be loaded properly and are not remaining on the applier.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8326516
• MDR Text Key: 135747715
• Report Number: 3003898360-2019-00212
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K152081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73G1800292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1